The U.S Food and Drug Administration (FDA) issued a Class 2 device recall of the Ottobock Kenovo prosthetic knee joint, model 3C60=ST and model 3C60. According to the notice, Ottobock discovered that the pylon may break if the device is used longer than 1.45 million cycles –or approximately 2.3 years of heavy use — and the pylon clamp is tightened in excess of labeled torque specifications
Ottobock Kenovo knee joint under FDA recall
The U.S Food and Drug Administration (FDA) issued a Class 2 device recall of the Ottobock Kenovo prosthetic knee joint, model 3C60=ST and model 3C60. According to the notice, Ottobock discovered that the pylon may break if the device is used longer than 1.45 million cycles –or approximately 2.3 years of heavy use — and the pylon clamp is tightened in excess of labeled torque specifications